Acetaminophen

Product NDC
68071-2201
11-digit product format
680712201
Labeler code
68071
Product ID
68071-2201_d738d60d-9eff-09cd-e053-2995a90a17da
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-10-18
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
325 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-2201DDiscontinued by firm2026-10-12
excluded packagepackage68071-220168071-2201-3DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-2201-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-2201-3f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2201-32022-02-04C16284748780-1d6a99b39-a9e0-a426-e053-dadaa90af4c2Major Pharmaceuticals Acetaminophen Drug Facts
68071-2201-32022-01-28C16284748780-1d6a99b39-a9e0-a426-e053-dadaa90af4c2Major Pharmaceuticals Acetaminophen Drug Facts

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2201-36807122010330 TABLET in 1 BOTTLE (68071-2201-3) 30 tablet2020-06-260000-00-00NoNoCurrent